Valvular Heart DiseaseNCT04993963
Prehabilitation and Heart Valve Surgery
A study testing Cycle Ergometery Training (Prehabilitation) in people with Valvular Heart Disease, run by Riphah International University at 1 site in Pakistan.
Trial summary
To evaluate the impact of prehabilitation on quality of recovery in heart valve surgery. To evaluate the effects of Mild to moderate valvular diseases with Newyork Heart Association (NYHA) grade I and II . Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Valvular Heart Disease
- What is being tested?
- Cycle Ergometery Training (Prehabilitation)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2021to 30 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients awaiting heart valve surgery for repair or replacement
- Both gender
- Mild to moderate valvular diseases
- NYHA grade I and II
- Pre-frail to moderately frail patients with a CFS of 4-6
- Patients with an estimated 6-8 weeks of surgical waiting list time.
- Able to perform 6MWT at baseline with RPE<13
Who cannot join
- Patients with severe left ventricular obstructive disease (severe aortic or mitral stenosis and dynamic left ventricular outflow obstruction).
- Patients with unstable or recently unstable cardiac syndrome
- Other than valve surgeries e.g. CABG
- Hospitalization for arrhythmias/ congestive heart failure
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Pakistan Institute of medical sciences (PIMS)
Islamabad, Punjab Province, 46000
About this study
Official title: Impact of Prehabilitation on the Quality of Recovery (QoR) After Heart Valve Surgery.
To evaluate the impact of prehabilitation on quality of recovery in heart valve surgery. To evaluate the effects of Mild to moderate valvular diseases with Newyork Heart Association (NYHA) grade I and II . Previous studies were designed to target on Coronary artery bypass graft surgery (CABGs) patients no specifically heart valve surgery patients was studied so this study cover this aspect as well so from the outcomes of this study we will determine the prehabilitation effects on valvular surgery patients.
Read the detailed description
A review stated that " the concept of prehabilitation has entered the forefront which encompasses multidisciplinary interventions to improve health and lessen the incidence of postoperative decline.
In the previous study held in pre-operative assessment clinic between March 2016 and August 2016, evaluated that PREHAB programme for frail patients undergoing CABG or Valve surgery may be able to improve functional ability and reduce hospital length of stay for those patients undergoing cardiac surgery.
previous other studies, parental study which is PREQUEL study recruitment started in July 2018 expect patient recruitment and 3 months of follow-up will be completed in June 2022 then their analysis will be done.
To improve functional and enhance the resources and postoperative recovery, prehabilitation plays a very cardial role. In some studies, it has been noticed that preoperative improvement in physical fitness, improve functional capacity all this is the part of the model for improving post-surgery recovery, this could play a vital role.
- Conditions
- Valvular Heart Disease
- Being tested
- Cycle Ergometery Training (Prehabilitation), Control Standard Group
- Keywords
- prehabilitation, quality of recovery, heart valve surgery
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cycle Ergometery Training (Prehabilitation)Other
Interval training on cycle ergometer: between 40% and 60% Vo2max, perceived exertion <13 on Borg scale 20-30 min/session/day (intermittent of exercise 2-3 mint, followed by 1-2 min of active recovery) Cool down (5 minutes) AROM +Body stretch
Control Standard GroupOther
Breathing exercise 15 Reps and Walk (10-15 minutes)
| Study group | Role | What they receive |
|---|---|---|
| Cycle Ergometery Training (Prehabilitation) | Experimental | Hospital-based ergometer cycling for 20 minutes (Including warm-up and cooldown) Interval training on cycle ergometer: between 40% and 60% Vo2max, perceived exertion <13 on Borg scale Receives: Other: Cycle Ergometery Training (Prehabilitation) |
| Control Standard Group | Active comparator | Breathing exercise 15 Reps and Walk (10-15 minutes) Receives: Other: Control Standard Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of recovery
15-item Quality of Recovery (QoR-15) is one of the standardized outcomes for assessing patient comfort after surgery. The QoR-15 score includes the items measuring pain, physical comfort, physical independence, psychological support, and emotional state. The QoR-15 score runs from 0 to 150. Higher scores indicate better Quality of life.
Measured: After 6 weeks, 1 month after CABG
Clinical Frailty Score
Frailty is a valid and clinically important construct that is recognizable by physicians. Clinical judgments about frailty can yield useful predictive information. Initial Clinical Frailty Scale assessment had access to diagnoses and assessments related to these variables and other measures of comorbidity, function, and associated features that inform clinical judgments about the severity of frailty. It was modified to a 9-point scale to include very severely frail and terminally ill. It evaluates specific domains, including comorbidity, function, and cognition, to generate a frailty score ranging from 1 (very fit) to 9 (terminally ill).
Measured: After 6 weeks, 1 month after CABG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start1 Feb 2021
- Primary completion15 Aug 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Valvular Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mehwish Waseem, MSPT(CPPT), Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04993963
- Sponsor's protocol ID
- Rec/00881 Tayyaba kiran
- Status last verified
- Sep 2021
- First submitted
- 5 Aug 2021
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Milder DA, Pillinger NL, Kam PCA. The role of prehabilitation in frail surgical patients: A systematic review. Acta Anaesthesiol Scand. 2018 Nov;62(10):1356-1366. doi: 10.1111/aas.13239. Epub 2018 Aug 10.
PubMed 30094821McCann M, Stamp N, Ngui A, Litton E. Cardiac Prehabilitation. J Cardiothorac Vasc Anesth. 2019 Aug;33(8):2255-2265. doi: 10.1053/j.jvca.2019.01.023. Epub 2019 Jan 12.
PubMed 30765210Steinmetz C, Bjarnason-Wehrens B, Baumgarten H, Walther T, Mengden T, Walther C. Prehabilitation in patients awaiting elective coronary artery bypass graft surgery - effects on functional capacity and quality of life: a randomized controlled trial. Clin Rehabil. 2020 Oct;34(10):1256-1267. doi: 10.1177/0269215520933950. Epub 2020 Jun 16.
PubMed 32546065Norris CM, Close JCT. Prehabilitation for the Frailty Syndrome: Improving Outcomes for Our Most Vulnerable Patients. Anesth Analg. 2020 Jun;130(6):1524-1533. doi: 10.1213/ANE.0000000000004785.
PubMed 32384342
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Prehabilitation on the Quality of Recovery (QoR) After Heart Valve Surgery.
- ClinicalTrials.gov ID
- NCT04993963
- Acronym / sponsor ID
- Rec/00881 Tayyaba kiran
- Conditions
- Valvular Heart Disease
- Keywords
- prehabilitation, quality of recovery, heart valve surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 15 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 6 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the impact of prehabilitation on quality of recovery in heart valve surgery. To evaluate the effects of Mild to moderate valvular diseases with Newyork Heart Association (NYHA) grade I and II . Previous studies were designed to target on Coronary artery bypass graft surgery (CABGs) patients no specifically heart valve surgery patients was studied so this study cover this aspect as well so from the outcomes of this study we will determine the prehabilitation effects on valvular surgery patients.
Detailed description
A review stated that " the concept of prehabilitation has entered the forefront which encompasses multidisciplinary interventions to improve health and lessen the incidence of postoperative decline.
In the previous study held in pre-operative assessment clinic between March 2016 and August 2016, evaluated that PREHAB programme for frail patients undergoing CABG or Valve surgery may be able to improve functional ability and reduce hospital length of stay for those patients undergoing cardiac surgery.
previous other studies, parental study which is PREQUEL study recruitment started in July 2018 expect patient recruitment and 3 months of follow-up will be completed in June 2022 then their analysis will be done.
To improve functional and enhance the resources and postoperative recovery, prehabilitation plays a very cardial role. In some studies, it has been noticed that preoperative improvement in physical fitness, improve functional capacity all this is the part of the model for improving post-surgery recovery, this could play a vital role.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cycle Ergometery Training (Prehabilitation) | Experimental | Other: Cycle Ergometery Training (Prehabilitation)Hospital-based ergometer cycling for 20 minutes (Including warm-up and cooldown) Interval training on cycle ergometer: between 40% and 60% Vo2max, perceived exertion <13 on Borg scale |
| Control Standard Group | Active comparator | Other: Control Standard GroupBreathing exercise 15 Reps and Walk (10-15 minutes) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Patients awaiting heart valve surgery for repair or replacement
- Both gender
- Mild to moderate valvular diseases
- NYHA grade I and II
- Pre-frail to moderately frail patients with a CFS of 4-6
Key exclusion criteria (4 listed)
- Patients with severe left ventricular obstructive disease (severe aortic or mitral stenosis and dynamic left ventricular outflow obstruction).
- Patients with unstable or recently unstable cardiac syndrome
- Other than valve surgeries e.g. CABG
- Hospitalization for arrhythmias/ congestive heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cycle Ergometery Training (Prehabilitation)Interval training on cycle ergometer: between 40% and 60% Vo2max, perceived exertion <13 on Borg scale 20-30 min/session/day (intermittent of exercise 2-3 mint, followed by 1-2 min of active recovery) Cool down (5 minutes) AROM +Body stretch | Other | Cycle Ergometery Training (Prehabilitation) |
| Control Standard GroupBreathing exercise 15 Reps and Walk (10-15 minutes) | Other | Control Standard Group |
Primary outcome
Quality of recovery
Time frame: After 6 weeks, 1 month after CABG
15-item Quality of Recovery (QoR-15) is one of the standardized outcomes for assessing patient comfort after surgery. The QoR-15 score includes the items measuring pain, physical comfort, physical independence, psychological support, and emotional state. The QoR-15 score runs from 0 to 150. Higher scores indicate better Quality of life.
Clinical Frailty Score
Time frame: After 6 weeks, 1 month after CABG
Frailty is a valid and clinically important construct that is recognizable by physicians. Clinical judgments about frailty can yield useful predictive information. Initial Clinical Frailty Scale assessment had access to diagnoses and assessments related to these variables and other measures of comorbidity, function, and associated features that inform clinical judgments about the severity of frailty. It was modified to a 9-point scale to include very severely frail and terminally ill. It evaluates specific domains, including comorbidity, function, and cognition, to generate a frailty score ranging from 1 (very fit) to 9 (terminally ill).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
- Background: PubMed 30094821Milder DA, Pillinger NL, Kam PCA. The role of prehabilitation in frail surgical patients: A systematic review. Acta Anaesthesiol Scand. 2018 Nov;62(10):1356-1366. doi: 10.1111/aas.13239. Epub 2018 Aug 10.
- Background: PubMed 30765210McCann M, Stamp N, Ngui A, Litton E. Cardiac Prehabilitation. J Cardiothorac Vasc Anesth. 2019 Aug;33(8):2255-2265. doi: 10.1053/j.jvca.2019.01.023. Epub 2019 Jan 12.
- Background: PubMed 32546065Steinmetz C, Bjarnason-Wehrens B, Baumgarten H, Walther T, Mengden T, Walther C. Prehabilitation in patients awaiting elective coronary artery bypass graft surgery - effects on functional capacity and quality of life: a randomized controlled trial. Clin Rehabil. 2020 Oct;34(10):1256-1267. doi: 10.1177/0269215520933950. Epub 2020 Jun 16.
- Background: PubMed 32384342Norris CM, Close JCT. Prehabilitation for the Frailty Syndrome: Improving Outcomes for Our Most Vulnerable Patients. Anesth Analg. 2020 Jun;130(6):1524-1533. doi: 10.1213/ANE.0000000000004785.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehwish Waseem, MSPT(CPPT) principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cycle Ergometery Training (Prehabilitation) in people with Valvular Heart Disease, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of recovery (time frame: After 6 weeks, 1 month after CABG). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04993963, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2021.